Allopurinol

ANDA 78253, held by Northstar Hlthcare. Allopurinol.

As of Nov 15, 2026, ANDA 78253 (Allopurinol), held by Northstar Hlthcare, was first approved by FDA on Sep 11, 2007, with 5 approved supplements and 0 published complete response letters.

First approved: Sep 11, 2007
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Sep 11, 2007	Original application	Approved	None posted

Products

2 strengths and forms


Allopurinol100MG · tablet;oral	Allopurinol	Discontinued
Allopurinol300MG · tablet;oral	Allopurinol	Discontinued

All 6 submissions, including labeling and manufacturing supplements


May 31, 2024	Supplement 13Labeling · Standard review	Approved	None posted
Apr 23, 2019	Supplement 12Labeling · Standard review	Approved	None posted
May 1, 2015	Supplement 5Labeling · Standard review	Approved	None posted
May 1, 2015	Supplement 6Labeling · Standard review	Approved	None posted
Dec 31, 2011	Supplement 4Labeling	Approved	None posted
Sep 11, 2007	Original application	Approved	None posted

Identifiers

Application: ANDA 78253
Drugs@FDA: Overview at FDA
Company: Northstar Healthcare

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters